Regeneron Pharmaceuticals Inc. (REGN) and Sanofi said that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application or sBLA for Dupixent or dupilumab 300 mg weekly to treat adult and pediatric patients aged 12 years and older with eosinophilic esophagitis or EoE, a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow.
The target action date for the FDA decision on this investigational use is August 3, 2022.
Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.
In September 2020, the U.S. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE. Dupixent was also granted Orphan Drug designation for the potential treatment of EoE in 2017. Regulatory filings around the world are also planned in 2022.
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